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NCT03525678 · OUTCOME

Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline (Day 1) and Up to 186 weeks

What was measured

Blood samples were collected for analysis of:glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil),creatinine kinase (CK),creatinine, gamma glutamyl transferase (GGT),potassium (Pot), magnesium (Mg),sodium (Sod), phosphate (Ph) urate \& estimated glomerular filtration rate (eGFR). Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Grading was according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented.Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.

Analysis population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Reported measurements

Gl, Hyper, increase to Grade 3, n=94,95,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Gl, Hyper, increase to Grade 4, n=94,95,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Gl, Hypo, increase to Grade 3, n=94,95,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Gl, Hypo, increase to Grade 4, n=94,95,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Albumin, increase to Grade 3, n=94,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	7	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

Albumin, increase to Grade 4, n=94,98,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	98
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

ALP, increase to Grade 3, n=93,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

ALP, increase to Grade 4, n=93,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

ALT, increase to Grade 3, n=93,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

ALT, increase to Grade 4, n=93,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

AST, increase to Grade 3, n=93,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	7	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

AST, increase to Grade 4, n=93,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

T.Bil, increase to Grade 3, n=92,97,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

T.Bil, increase to Grade 4, n=92,97,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	92
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

CK, increase to Grade 3, n= 87,91,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	87
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

CK, increase to Grade 4, n= 87,91,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	87
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Creatinine, increase to Grade 3, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	3	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Creatinine, increase to Grade 4, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

GGT, increase to Grade 3, n= 91,95,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	5	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

GGT, increase to Grade 4, n= 91,95,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Pot, Hyper,increase to Grade 3, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Pot, Hyper,increase to Grade 4, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Pot, Hypo, increase to Grade 3, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	4	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

Pot, Hypo, increase to Grade 4, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Mg, Hyper, increase to Grade 3, n= 91,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Mg, Hyper, increase to Grade 4, n= 91,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Mg, Hypo, increase to Grade 3, n= 91,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Mg, Hypo, increase to Grade 4, n= 91,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	91
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Phosphate, increase to Grade 3, n= 90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	8	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2	Not reported	Not reported	Not reported	Not reported

Phosphate, increase to Grade 4, n= 90,93,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	90
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Sod, Hyper, increase to Grade 3, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Sod, Hyper, increase to Grade 4, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Sod, Hypo, increase to Grade 3, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

Sod, Hypo, increase to Grade 4, n= 95,97,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Urate, increase to Grade 3, n= 93,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Urate, increase to Grade 4, n= 93,96,24

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	93
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1	Not reported	Not reported	Not reported	Not reported

eGFR, increase to Grade 3, n= 84,85,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	85
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	8	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

eGFR, increase to Grade 4, n= 84,85,23

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	84
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	85
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1	Not reported	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
95
group Id
OG002
value
24
units
Participants
title
Gl, Hyper, increase to Grade 3, n=94,95,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
95
group Id
OG002
value
24
units
Participants
title
Gl, Hyper, increase to Grade 4, n=94,95,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
95
group Id
OG002
value
24
units
Participants
title
Gl, Hypo, increase to Grade 3, n=94,95,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
95
group Id
OG002
value
24
units
Participants
title
Gl, Hypo, increase to Grade 4, n=94,95,24
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
7
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
98
group Id
OG002
value
24
units
Participants
title
Albumin, increase to Grade 3, n=94,98,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
98
group Id
OG002
value
24
units
Participants
title
Albumin, increase to Grade 4, n=94,98,24
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
ALP, increase to Grade 3, n=93,97,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
ALP, increase to Grade 4, n=93,97,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
ALT, increase to Grade 3, n=93,97,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
97
group Id
OG002
value
24
units
Participants
title
ALT, increase to Grade 4, n=93,97,24
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
96
group Id
OG002
value
24
units
Participants
title
AST, increase to Grade 3, n=93,96,24
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
93
group Id
OG001
value
96
group Id
OG002
value
24
units
Participants
title
AST, increase to Grade 4, n=93,96,24

denoms

counts
group Id
OG000
value
95
group Id
OG001
value
99
group Id
OG002
value
24
units
Participants

description

Blood samples were collected for analysis of:glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil),creatinine kinase (CK),creatinine, gamma glutamyl transferase (GGT),potassium (Pot), magnesium (Mg),sodium (Sod), phosphate (Ph) urate \& estimated glomerular filtration rate (eGFR). Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Grading was according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented.Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.

groups

description
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
id
OG000
title
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
description
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
id
OG001
title
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
description
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
id
OG002
title
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

param Type

COUNT_OF_PARTICIPANTS

population Description

Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

reporting Status

POSTED

time Frame

Baseline (Day 1) and Up to 186 weeks

title

Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice